Clinical Studies
Orsiro has an extensive clinical program with more than 55,000 patients enrolled3.
Orsiro has an extensive clinical program with more than 55,000 patients enrolled3.
Clinical studY Highlights
Orsiro DES, improving patient outcomes, year after year*
BIOFLOW-V: 3-year results from the FDA pivotal trial
*Compared to Xience, based on three consecutive years.
1. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 2. Based on investigator’s interpretation of BIOFLOW-V primary endpoint results; 3. BIOTRONIK data on file, status January 2020.
Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.
Brief Summary
Indications:
Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.
Contraindications: Orsiro is contraindicated for use in patients with a known hypersensitivity or allergy to the stent and/or stent coating materials such as amorphous silicon carbide, PLLA polymer, L-605 cobalt chromium alloy (including the major elements cobalt, chromium, tungsten and nickel), sirolimus or its derivatives.
Coronary artery stenting is contraindicated for use in the following patients:
Warnings
Precautions
General:
Pre- and Post-procedure Antiplatelet Therapy Recommendations: Antiplatelet/anticoagulation medication should be used in combination with Orsiro. Physicians should consider the information from the current drug-eluting stent literature and the current ACC/AHA guideline recommendations on PCI concerning the selection, dosage, duration and combination of different antithrombotic drugs. Specific needs and the risk profile of individual patients may influence the antiplatelet/anticoagulation regime to be used. The optimal duration of antiplatelet therapy, specifically P2Y12 inhibitor therapy, is unknown and DES thrombosis may still occur despite continued therapy.
Oral Antiplatelet Therapy: Dual antiplatelet therapy (DAPT) using a combination treatment of aspirin with a P2Y12 platelet inhibitor after percutaneous coronary intervention (PCI) reduces the risk of stent thrombosis and ischemic cardiac events but increases the risk of bleeding complications. The optimal duration of DAPT (specifically, a P2Y12 platelet inhibitor in addition to aspirin) following DES implantation is unknown, and DES thrombosis may still occur despite continued therapy. It is very important that the patient is compliant with the post-procedural antiplatelet recommendations. Per 2016 ACC/AHA guidelines, a daily aspirin dose of 81 mg is recommended indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at least 6 months in stable ischemic heart disease patients and for at least 12 months in patients with acute coronary syndrome (ACS). Consistent with the DAPT Study and the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in patients at higher ischemic risk with lower bleeding risk. In patients at higher risk of bleeding, DAPT discontinuation may be reasonable after 3 months in stable patients or 6 months in ACS patients. Decisions about the duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, and patient preference. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of stent thrombosis, MI or death.
Refer to the Orsiro Instructions for Use (IFU) for additional precautions related to handling and stent Placement. Refer to the “MRI Safety Information” section of the Orsiro IFU for the stent’s MRI compatibility information.
The safety and effectiveness of Orsiro have not yet been established in patients with the following:
Potential Adverse Events
Cardiac events: MI or ischemia, abrupt closure of coronary artery, restenosis of treated artery (greater than 50% obstruction), cardiogenic shock, angina, tamponade, perforation or dissection of coronary artery or aorta, cardiac perforation, emergency cardiac surgery, pericardial effusion and aneurysm formation. Arrhythmic events: ventricular tachycardia, ventricular fibrillation, atrial fibrillation and bradycardia. Stent system events: failure to deliver stent to intended site, stent dislodgement from the delivery system, stent misplacement, stent deformation, stent embolization, stent thrombosis or occlusion, stent fracture, stent migration, inadequate apposition or compression of stent/s, inflation difficulties, rupture or pinhole of the delivery system balloon, deflation difficulties, withdrawal difficulties and embolization of catheter material. Respiratory events: acute pulmonary edema, congestive heart failure and respiratory insufficiency or failure. Vascular events: access site hematoma, hypotension/hypertension, pseudoaneurysm, arteriovenous fistula formation, retroperitoneal hematoma, vessel dissection or perforation, restenosis, thrombosis or occlusion, vasospasm, peripheral ischemia, dissection and distal embolization (air, tissue debris and thrombus). Neurologic events: permanent (stroke) or reversible (TIA) neurologic event, femoral nerve injury and peripheral nerve injury. Bleeding events: access site bleeding or hemorrhage, hemorrhage requiring transfusion or other treatment. Allergic reactions to contrast media, antiplatelets, anticoagulants, amorphous silicon carbide, L-605 cobalt chromium alloy, PLLA polymer matrix, sirolimus or sirolimus derivatives. Death. Infection and sepsis. Furthermore, all procedure-related adverse events as described in the national and international guidelines of the respective medical associations apply. Potential adverse events related to the oral administration of sirolimus include, but are not limited to, abnormal liver function tests, anemia, arthralgia, diarrhea, hypercholesterolemia, hypersensitivity (including anaphylactic/anaphylactoid type reactions), hypertriglyceridemia, hypokalemia, infections, interstitial lung disease, thrombocytopenia, leukopenia, lymphoma and other malignancies.
Please reference the appropriate product Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.